K-number	K113533
Device name	NEURO CHECK DEVICE WITH IO-FLEX WIRE
Applicant	Baxano, Inc.
Product code	HAE
Device class	Class II
Decision date	Apr 11, 2012
Decision	Substantially Equivalent
Regulation	882.4840

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Source

View the full FDA submission: accessdata.fda.gov

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NEURO CHECK DEVICE WITH IO-FLEX WIRE

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